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K Number
K955331

Validate with FDA (Live)

Device Name
BELLEGLASHP
Manufacturer
SYBRON DENTAL SPECIALTIES, INC.
Date Cleared
1996-01-02

(43 days)

Product Code
EBG
Regulation Number
872.3770
Type
Traditional
Panel
Dental
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K982164,K982259
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 872.3770 Temporary crown and bridge resin.

(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.